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Safety of Two Epidural Catheters in Thoracic Epidural Anaesthesia (TEA)

NCT00394459 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2011-05-13

No results posted yet for this study

Summary

Primary Objective: The primary objective is to demonstrate that the safety of Perifix New is non-inferior to using Perifix Standard when applied for thoracic epidural anaesthesia.

Primary Endpoint: Incidence of spontaneous paraesthesia during catheter insertion

Secondary Objectives: The secondary objectives are to determine the safety and performance of the investigational product: frequency of inadvertent vascular cannulation, difficulties involved in insertion and removal of the catheter, other safety features and data for the evaluation of handling characteristics.

Title: Randomised, prospective, single-blind, controlled, study on the safety of two epidural catheters in patients undergoing surgery under thoracic epidural anaesthesia

Investigational Product: Perifix Epidural Anaesthesia Catheter

Test Product: Perifix New

Reference Product: Perifix Standard

Number of Sites and Countries: 1 site in The Netherlands

Indication: Thoracic epidural anaesthesia

Study Design: Randomised, prospective, single-blind, controlled study in 1 study center, phase IV

Perifix New and Perifix Standard meet all the appropriate provisions of the relevant legislation implementing European Directives (both have CE-marking).

Study Duration: 2 year duration

Study Start: March-April 2005

Sample Size: n = 2\*70 patients

Conditions

  • Anesthesia, Epidural
  • Paraesthesia

Interventions

DEVICE

Perifix Epidural Anaesthesia Catheter

Epidural Catheter

DEVICE

Perifix Standard

Perifix Standard

DEVICE

Perifix New

Perifix New

Sponsors & Collaborators

  • B. Braun Melsungen AG

    collaborator INDUSTRY

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Mathieu Gielen, MD, PhD · Radboud University Medical Center

  • Marco Marcus, MD, PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2008-03-31
Completion
2009-05-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00394459 on ClinicalTrials.gov